Engineer II - Lab Operation and Process

Arthrex•Pelican Bay, FL

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer II – Laboratory Operations and Process. This individual will be responsible for managing operations and efficiencies of the Orthopedic Research Biomedical Engineering Laboratory and ensure the procedures, equipment, and personnel are compliant under the Quality Management System. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

General knowledge of orthopedic devices and surgical procedures.
Proficient at Good Laboratory Practices and Good Documentation Practices.
Working knowledge of mechanical and chemical test methods, able analyze data, and perform statistical analyses.
Working knowledge of ISO 13485 and applicable Quality Systems and regulatory standards and requirements.
Operates successfully within the Arthrex QMS.
Bachelors Degree in Engineering required.
2 years of scientific laboratory or quality engineering experience required, OR 1 years experience with a Masters Degree, OR PhD.
PC and software as needed, including MS Office Suite.
Able to operate and maintain standard surgical tools and equipment.
Ability to understand mechanical and chemical testing devices, their use, and their upkeep.
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
Ability to verbally communicate ideas and issues effectively to other team members and management.
Ability to write and record data and information as required by procedures.

Responsibilities

Optimize the lab environment for the Biomaterials Research, Biomechanics Research, and Biomechanical Testing Teams.
Manage all equipment maintenance and gauge calibrations.
Track usage, forecast, and maintain lab supply inventory and purchasing.
Provide a point of contact for all facilities, IT/GIS, EH&S, and outside vendors.
Manage lab safety trainings and provide/promote a safe laboratory environment, including maintaining PPE supplies.
Maintain, update, and author quality documents within the QMS document management system.
Verify training activities and maintain training records for lab personel.
Represent the Research Department during internal and agency audits of the laboratories.
Complete NCR and CAPA activities including disposition plans, evaluations, and action plans.
Assess quality risks and implement mitigation strategies.
Lead equipment validation activities and process documentation (IQ/OQ).
Analyze lab activities with respect to compliance to ISO 13485 and other applicable regulatory or quality standards, and make change recommendations to departmental leadership.
Participate in training current and future Biomedical Engineering employees.
Manage priorities and deliverables for multiple simultaneous projects per determined schedule and respond to special assigned projects as needed.
Assist Biomedical Engineering Team members with research activities, including but not limited to sample preparation, testing, and data analysis
Maintain accurate records.
Track lab metrics and provide reports to the Biomedical Engineering Leadership.